EndoArmor™ SGE-368-10

GUDID 00816849010281

EndoArmor Gown

BOSTON SCIENTIFIC CORPORATION

Isolation gown, single-use

• Primary Device ID: 00816849010281
• NIH Device Record Key: c56e9a36-9b37-4c81-867b-1660e4876863
• Commercial Distribution Discontinuation: 2024-04-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EndoArmor™
• Version Model Number: SGE-368-10
• Catalog Number: SGE-368-10
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816849010281 [Package]; Contains: 08714729989332; Package: [10 Units]; Discontinued: 2024-04-26; Not in Commercial Distribution
GS1	08714729989332 [Primary]
GS1	08714729989592 [Unit of Use]

FDA Product Code

• OEA: Non-surgical isolation gown

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-17
• Device Publish Date: 2019-02-18

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729424260 - Contour™: 2024-09-11 Ureteral Stent Set
• 08714729462583 - Contour™: 2024-09-11 Ureteral Stent Set
• 08714729462651 - Contour™: 2024-09-11 Ureteral Stent Set
• 08714729462798 - Contour™: 2024-09-11 Ureteral Stent Set
• 00191506020798 - RHYTHMIA HDx™: 2024-09-11 Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™)
• 00191506020804 - RHYTHMIA HDx™: 2024-09-11 Ablation Connection Box (for INTELLAGEN™)
• 08714729010975 - Connector: 2024-09-09 FOR 7F THROUGH 10F CATHETERS WITH LUER LOCK FITTING Ureteral Catheter Connector
• 08714729010982 - Connector: 2024-09-09 FOR 3F THROUGH 6F CATHETERS WITH LUER LOCK FITTING Ureteral Catheter Connector